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NCT01417000 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of Combination Listeria/GVAX Immunotherapy in Pancreatic Cancer
A Phase 2 study, sponsored by Aduro Biotech.
- Completed
- Registry status
- Phase 2
- Development phase
- 93
- Enrollment target
NCT01417000: Completed Phase 2 study, sponsored by Aduro Biotech.
NCT01417000 is a Phase 2 study that has completed, run by Aduro Biotech. The registered enrollment target is 93 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (30% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01417000, a Phase 2 study, has completed, sponsored by Aduro Biotech.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 93 participants
- Enrollment target
Study Summary
Test the safety, immune response and efficacy of GVAX pancreas vaccine (with cyclophosphamide) and CRS-207 compared to GVAX pancreas vaccine (with cyclophosphamide) alone in adults who have failed or refused prior treatment for metastatic pancreatic cancer.
Primary Outcome
For all treated subjects, OS was defined as the time between the date of randomization and the date of death or censoring, and was estimated using Kaplan-Meier (KM) methods with 95% confidence intervals (CIs). Subjects without documentation of death at the time of the final analysis were censored using the date the subject was last known to be alive. Per the study protocol, following an Interim Analysis (IA), subjects in the Cy/GVAX arm were offered rollover to Cy/GVAX + CRS-207 arm. 3 subjects
Interventions
- DRUG Cyclophosphamide
- BIOLOGICAL CRS-207
- BIOLOGICAL GVAX Pancreas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 93 participants |
| Start Date | 2011-09-21 |
| Est. Completion | 2017-02-10 |
| Phase | Phase 2 |
What the finished NCT01417000 record still lists
NCT01417000 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 93 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (30% lower).
The record links to 0 conditions, and to 3 interventions - of which Cyclophosphamide is the first listed.
NCT01417000 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01417000 about?
NCT01417000 is a clinical study titled "Safety and Efficacy of Combination Listeria/GVAX Immunotherapy in Pancreatic Cancer". Test the safety, immune response and efficacy of GVAX pancreas vaccine (with cyclophosphamide) and CRS-207 compared to GVAX pancreas vaccine (with cyclophosphamide) alone in adults who have failed or refused prior treatment for metastatic pancreatic cancer.
What is the current status of trial NCT01417000?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 93 participants. The study started on 2011-09-21. Estimated completion is 2017-02-10.
What interventions are being tested in trial NCT01417000?
The interventions under investigation include: Cyclophosphamide (DRUG), CRS-207 (BIOLOGICAL), GVAX Pancreas (BIOLOGICAL).
Who is sponsoring clinical trial NCT01417000?
This trial is sponsored by Aduro Biotech, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01417000's enrollment target sits among peer trials
93 766th of 2000 higher than 1,234 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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